CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision

Medtronic

Status: Completed

Conditions: Atrial Fibrillation; Arrhythmia; Tachycardia; Ventricular Fibrillation

Treatments: Other: In-Office Care; Other: Remote Management

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00402246

605

Details and patient eligibility

About

The purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen in-office for routine visits to check the status of their device.

Enrollment: 2,009 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient will be implanted with a Medtronic Conexus-enabled Cardiac Resynchronization Therapy Defibrillator (CRT-D) or Implantable Cardioverter-Defibrillator (DR-ICD) device.

Exclusion criteria

• Patient has permanent rapid beats in the upper chamber of the heart (Atrial Fibrillation) - (constant atrial fibrillation in which pharmacological therapy or cardioversion failed or not attempted).
• Patient plans to be on chronic warfarin therapy post-implant and is no longer receiving therapies to attempt to control the rhythm of the beats in their atrium.
• Patient has a previous ICD, CRT-D, Implantable Pulse Generator (IPG) or Cardiac Resynchronization Therapy Pacemaker (CRT-P).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,009 participants in 2 patient groups

Remote Arm

Experimental group

Description:

Remote Management

Treatment:

Other: Remote Management

In-office Arm

Active Comparator group

Description:

In-Office Care

Treatment:

Other: In-Office Care